DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claim 1 is pending in this application. Claims 2-6 have been cancelled by applicant.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Nam et al. (EP 3,329,910 A1 – Pub. Date: June 6th, 2018 – previously cited) (“Nam”); further in view of Westerberg et al. (American Family Physician, 2013, 88, 762-770 – previously cited) (“Westerberg”); Rothman et al. (Obtained from rothmanortho.com [retrieved on 01/02/2026] <URL:https://rothmanortho.com/stories/blog/toe-nail-fungus> - Pub. Date: May 1st, 2015) (“Rothman”); and Sparavigna et al. (Clinical, Cosmetic and Investigational Dermatology, 2019, 12, 355-362 – previously cited) (“Sparavigna”).
Regarding claim 1, Nam discloses a topical pharmaceutical composition for preventing or treating onychomycosis comprising 15-25 wt% urea, 0.5-2.5 wt% fumaric acid, 8-18 wt% 1,3-butylene glycol, 5-10 wt% a gel forming polymer, 0.1 to 0.5 wt% of a crosslinking agent, and 45-60 wt% water, wherein the composition is in a hydrogel form and has keratolysis and moisture-retention abilities (Nam’s claims 1-6 and [009]). Nam also discloses administration of their composition in the form of a patch see drawings and [0012] and [0023].
While Nam does not specifically teach their formulation further comprising biotin or the treatment of ingrown toenail pain while enhancing nail growth; the teachings of Westberg, Rothman, and Sparavigna are relied upon for these disclosures.
Westberg teaches different classifications of onychomycoses and their clinical features based on the destructive effects of the nail structure, leading to discoloration, chipping, thickening, and lamellar splitting (Table 1, page 763).
Rothman teaches sometimes ingrown toenails result from the development of fungus beneath the nail - An injury to the nail bed or nail plate may facilitate the growth of toenail fungus pain and that fungus can then, in turn, cause unusual nail growth that eventually leads to an ingrown toenail (page 1, 2nd to last para.).
Sparavigna teaches that clinical trials showed an improvement in the firmness, hardness, and thickness of brittle nails in subjects treated with oral biotin (page 356, col. 1, last 2 lines, to col. 3, line 1). Sparavigna discloses the effects of a topical formulation comprising biotin on nail hardness (Figure 2 and 3A) disclosing up to 40% increase after 3 months of treatment compared to baseline, and improvement of lamellar splitting (page 358, col. 2, para. 2). Sparavigna further teaches that biotin is among the nutrients needed to improve nail condition (page 356, col. 2, para. 2, last 3 lines). Sparavigna discloses improved nail growth in biotin treated subjects (abstract – results, last 2 lines).
Therefore, regarding claim 1, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer Nam’s formulation, further comprising biotin, for the treatment of onychomycosis and ingrown toenail pain related to fungal infection, in view of Westberg, Rothman, and Sparavigna. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Nam’s disclosure of a patch formulation capable of treating onychomycosis; Westberg’s teachings that onychomycoses compromise nail structure, leading to discoloration, chipping, and lamellar splitting; Rothman’s teaching that fungal infections may result in ingrown toenails, which are painful and cause discomfort in subjects; and Sparavigna’s disclosure that their topical formulation comprising biotin can improve nail hardness and lamellar splitting, as well as improve growth and general nail condition.
Regarding the instantly claimed ranges for the components of the composition, Applicant is advised that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05-II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Response to Arguments
Claims
Claim amendments are acknowledged. No new matter has been introduced.
Specification
Amendments to the specification are acknowledged and have been entered. Objections to the specification are withdrawn.
Claim Rejections - 35 USC § 112(a)
Applicant’s arguments, see page 4, filed 12/16/2025, with respect to 35 USC § 112(a) rejections have been fully considered and are persuasive. The 35 USC § 112(a) rejection of claims has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see page 4, filed 12/16/2025, with respect to 35 USC § 103 rejections over Nam, Westerberg, and Sparavigna have been fully considered and are persuasive. The 35 USC § 103 rejection of claims has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Nam, Westerberg, Rothman, and Sparavigna – new ground of rejection was necessitated by applicant’s amendment.
Applicant argues that Nam’s composition alone does not include the required 0.1 wt% biotin component. Applicant states Westerberg and Sparavigna do not cure this deficiency because no disclosure “in Westerberg teaches incorporating biotin into Nam’s hydrogel composition or into a hydrogel patch, having the recited wt% formulation”. Applicant states no disclosure in Sparavigna teaches a hydrogel patch with the claimed combination and 0.1 wt% biotin as claimed. Applicant states no disclosure in Westberg or Sparavigna teaches or suggests modifying Nam’s composition to arrive at the claimed hydrogel patch composition with 0.1 wt% biotin, and states that the combination fails to suggest a method of topically administering in the form of a hydrogel patch. Applicant states the claimed invention exhibits unexpected results for relieving ingrown toenail pain by providing “immediate relief from ingrown toenail pain and inflammation” citing test example 4 of the spec. and states that Sparavigna only teaches that biotin improves nail hardness and prevents splitting. Applicant states one of ordinary skill would not have expected that adding a nail-hardening agent would help relieve pain caused by nail growing into flesh, and that this therapeutic effect is distinct and unexpected and goes beyond routine optimization.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument that Sparavigna teaches biotin as a nail-hardening agent; or that Nam doesn’t disclose a hydrogel patch formulation; etc. Applicant is advised that the courts have stated “[A] prior art reference must be considered in its entirety, i.e., as a whole” W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983) (see MPEP 2141.02 VI). Thus, while the rejections listed above present a modified interpretation of the teachings of the previously cited prior solely for the purpose of clarity, the claims remain rejected over the prior art of record.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Nam discloses a topical pharmaceutical composition for preventing or treating onychomycosis comprising 15-25 wt% urea, 0.5-2.5 wt% fumaric acid, 8-18 wt% 1,3-butylene glycol, 5-10 wt% a gel forming polymer, 0.1 to 0.5 wt% of a crosslinking agent, and 45-60 wt% water, wherein the composition is in a hydrogel form and has keratolysis and moisture-retention abilities (Nam’s claims 1-6 and [009]). Nam also discloses administration of their composition in the form of a patch (see drawings and [0012] and [0023]).
Westberg teaches different classifications of onychomycoses and their clinical features based on the destructive effects of the nail structure, leading to discoloration, chipping, thickening, and lamellar splitting (Table 1, page 763).
Rothman teaches sometimes ingrown toenails result from the development of fungus beneath the nail (reading on onychomycoses) - An injury to the nail bed or nail plate may facilitate the growth of toenail fungus pain and that fungus can then, in turn, cause unusual nail growth that eventually leads to an ingrown toenail (page 1, 2nd to last para.). Therefore, by treating a fungal infection, one is also preventing/ reducing the risk of/ treating ingrown toenail pain.
Sparavigna teaches the effects of a topical formulation comprising biotin on nail hardness (Figure 2 and 3A) disclosing up to 40% increase after 3 months of treatment compared to baseline, and improvement of lamellar splitting (page 358, col. 2, para. 2). Sparavigna further teaches that biotin is among the nutrients needed to improve nail condition (page 356, col. 2, para. 2, last 3 lines). Sparavigna discloses that their topical formulation comprising biotin can improve nail hardness and lamellar splitting, as well as improve growth and general nail condition (abstract – results, last 2 lines).
Therefore, regarding claim 1, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Nam’s hydrogel patch formulation further comprising biotin for the treatment of onychomycosis and ingrown toenail pain related to fungal infection in view of Westberg, Rothman, and Sparavigna. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Nam’s disclosure of a hydrogel patch formulation capable of treating onychomycosis; Westberg’s teachings that onychomycoses compromise nail structure, leading to discoloration, chipping, and lamellar splitting; Rothman’s teaching that fungal infections may result in ingrown toenails, which are painful and cause discomfort in subjects; and Sparavigna’s disclosure that their topical formulation comprising biotin can improve nail hardness and lamellar splitting, as well as improve growth and general nail condition. Therefore, it would have been obvious to combine Nam’s hydrogel patch composition for treating onychomycosis with Sparavigna’s biotin component to improve overall toenail health.
Regarding the instantly claimed ranges for the components of the composition (such a s 0.1 wt% biotin), Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
In response to applicant’s argument of unexpected results for relieving ingrown toenail pain by providing immediate relief from ingrown toenail pain and inflammation, citing test example 4 of the spec., these results on their own, are not persuasive. First, in Table 1 of the specification (page 15), none of the Formulation Examples disclosed seem to comprise any biotin. Second, in “Test Example 4” Applicant states, “the test subject (comprising biotin) had been changing the product, sometimes twice a day . . .” (starting [0070]). These statements, on their own, do not corroborate that inclusion of biotin into Nam’s hydrogel patch composition is responsible for accelerated healing of the ingrown toenail pain. Clear comparative data of the effects of Nam’s composition and the instantly claimed composition (comprising 0.1 wt% biotin) is needed to shift the obviousness argument of record to a potential allowance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627